Jounce Therapeutics to Present Safety and Preliminary Efficacy Data on JTX-4014 and a Trials in Progress Poster for the Vopra...
November 05 2019 - 8:05AM
Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today announced
presentations on two ongoing clinical programs, JTX-4014 and
vopratelimab, at the Society for Immunotherapy of Cancer’s (SITC)
34th Annual Meeting, being held November 6-10, 2019 in National
Harbor, Maryland.
“Our poster sessions at this year’s SITC conference demonstrate
the progress we have made to date on both of our clinical-stage
programs, vopratelimab, an ICOS agonist, and JTX-4014, a PD-1
inhibitor. We have previously shown the relationship between the
vopratelimab-associated emergence of ICOS hi CD4 T cells and
clinical benefit,” said Elizabeth Trehu, M.D., chief medical
officer of Jounce Therapeutics. “The EMERGE trial builds on the
biology of induction of ICOS hi CD4 T cells by ipilimumab and their
expansion and sustained activation by vopratelimab. We will provide
the scientific rationale for the unique dosing and sequencing
strategy of ipilimumab and vopratelimab in EMERGE, which we believe
optimizes ICOS hi CD4 T cell priming and agonist biology. In a
separate poster at SITC, the safety and preliminary efficacy data
for JTX-4014 being presented supports the use of this PD-1
inhibitor in combination with our other product candidates.”
Poster Presentation Details:
Title: Phase 1 First in Human Study of
Programmed Cell Death Receptor-1(PD-1) Inhibitor Monoclonal
Antibody (mAb) JTX-4014 in Adult Subjects with Advanced Refractory
Solid Tumor Malignancies Presentation Date and
Time: Friday, November 8, 2019, 7:00am – 8:00pm
ETPresenter: Kyriakos P. Papadopoulos,
M.D.Abstract ID: P439
Jounce researchers describe the safety, preliminary efficacy and
recommended Phase 2 doses for JTX-4014 including:
- Acceptable safety profile for JTX-4014 based on a 6-cohort
dose-escalation trial. There were no deaths or dose limiting
toxicities, few Grade 3/4 adverse events and the only related
serious adverse event (SAE) was pneumonitis, which occurred after
the second dose at 1200 mg Q3W.
- Antitumor activity observed with an overall response rate of
16.7% (3/18), including 1 complete response and 2 partial responses
(confirmed) in a difficult to treat population with no therapeutic
options.
- The disease control rate was 44.4% (8/18).
- Typical IgG4 profile with linear pharmacokinetics (PK).
- Planned Phase 2 studies utilizing recommended doses of either
500mg Q3W or 1000mg Q6W.
Title: Phase 2 Multicenter Trial of ICOS
Agonist Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor
Experienced Adult Subjects with Non-Small Cell Lung Cancer or
Urothelial Cancer (EMERGE)Presentation Date and
Time: Saturday, November 9, 2019, 7:00am – 8:30pm
ETPresenter: Russell K. Pachynski,
M.D.Abstract ID: P438
Jounce researchers highlight the scientific rationale for the
ongoing Phase 2 EMERGE trial including:
- Based on reverse translational findings from the ICONIC trial,
strategies to optimize emergence and expansion of ICOS hi CD4 T
cells have become a cornerstone of the vopratelimab development
program.
- The sequence of administration of ipilimumab and vopratelimab
combination in EMERGE is designed to induce ICOS hi CD4 T cells
with ipilimumab followed by their expansion and sustained
activation by vopratelimab.
- A pulsed dose and schedule for vopratelimab, designed to
optimize agonist antibody activity, is explored. Specifically, the
trial evaluates two different vopratelimab dose levels and a new
dosing interval.
Both posters will be available on the “Our Pipeline” section of
the Jounce Therapeutics website under “Publications” at
www.jouncetx.com.
About Vopratelimab Jounce’s lead product
candidate, vopratelimab (formerly JTX-2011), is a clinical-stage
monoclonal antibody that binds to and activates ICOS, the Inducible
T cell CO Stimulator, a protein on the surface of certain T cells
commonly found in many solid tumors. Vopratelimab was previously
assessed in the Phase 1/2 ICONIC trial and was found to be safe and
well-tolerated, alone and in combination with each of the anti-PD-1
antibodies nivolumab and pembrolizumab, and ipilimumab, an antibody
that binds to CTLA-4. In June 2018, Jounce reported Response
Evaluation Criteria in Solid Tumors (RECIST) responses and other
tumor reductions as determined by investigator assessment that were
associated with an ICOS pharmacodynamic biomarker, ICOS hi CD4 T
cells. In April 2019, Jounce reported data on patients in the
ICONIC trial with the emergence of ICOS hi CD4 T cells who had
improved progression free survival and overall survival compared to
patients with ICOS lo CD4 T cells; this was based on an analysis of
a subgroup of patients with multiple solid tumor types including
PD-1 inhibitor naive and PD-1 inhibitor experienced patients.
Vopratelimab is currently being assessed in the Phase 2 EMERGE
clinical trial in combination with ipilimumab in patients with
non-small cell lung cancer or urothelial cancer who have progressed
on or after PD-1/PD-L1 inhibitor therapies.
About JTX-4014JTX-4014 is a well-characterized
fully human IgG4 monoclonal antibody designed to block binding to
PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in
combination with its pipeline of future product candidates. Jounce
completed enrollment in the Phase 1 clinical trial of JTX-4014 and
additional studies with JTX-4014 with our other product candidates
are planned.
About Jounce TherapeuticsJounce Therapeutics,
Inc. is a clinical-stage immunotherapy company dedicated to
transforming the treatment of cancer by developing therapies that
enable the immune system to attack tumors and provide long lasting
benefits to patients through a biomarker-driven approach. Through
the use of its Translational Science Platform, Jounce first focuses
on specific cell types within the human tumor microenvironment to
prioritize targets, and then identifies related biomarkers designed
to match the right immunotherapy to the right patient. Jounce is
developing two clinical-stage programs as well as advancing and
building out its broad and wholly-owned discovery pipeline of
immuno-oncology targets, including those expressed on T-regulatory
cells, macrophages and stromal cells. Jounce’s lead product
candidate, vopratelimab, is a monoclonal antibody that binds to and
activates ICOS and is currently being assessed in a Phase 2
clinical trial. JTX-4014 is a PD-1 inhibitor intended for use in
combination with future pipeline products, and Jounce has completed
enrollment in the JTX-4014 Phase 1 clinical trial. In addition,
Jounce has exclusively licensed worldwide rights to JTX-8064, a
LILRB2 receptor antagonist, to Celgene. For more information,
please visit www.jouncetx.com.
Cautionary Note Regarding Forward-Looking
StatementsVarious statements in this release concerning
Jounce’s future expectations, plans and prospects, including
without limitation, Jounce’s expectations regarding the timing,
progress and results of the EMERGE clinical trial may constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of
1995 and other federal securities laws and are subject to
substantial risks, uncertainties and assumptions. You should not
place reliance on these forward-looking statements, which often
include words such as “will,” “plan,” “potential” or similar terms,
variations of such terms or the negative of those terms. Although
Jounce believes that the expectations reflected in the
forward-looking statements are reasonable, Jounce cannot guarantee
such outcomes. Actual results may differ materially from those
indicated by these forward-looking statements as a result of
various important factors, including, without limitation, Jounce’s
ability to successfully demonstrate the efficacy and safety of its
product candidates; the clinical results for its product
candidates, which may not support further development and marketing
approval; the potential advantages of Jounce’s product candidates;
the development plans of its product candidates and any companion
or complementary diagnostics; actions of regulatory agencies, which
may affect the initiation, timing and progress of preclinical
studies and clinical trials of Jounce’s product candidates; and
those risks more fully discussed in the section entitled “Risk
Factors” in Jounce’s most recent Annual Report on Form 10-K filed
with the Securities and Exchange Commission as well as discussions
of potential risks, uncertainties, and other important factors in
Jounce’s subsequent filings with the Securities and Exchange
Commission. All such statements speak only as of the date made, and
Jounce undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor Contact: Komal Joshi Jounce
Therapeutics, Inc. (857) 320-2523 kjoshi@jouncetx.com
Media Contact: Kathryn MorrisThe Yates
Network914-204-6412kathryn@theyatesnetwork.com
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